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BREO ELLIPTA Drug Profile

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Which patents cover Breo Ellipta, and what substitute generic drugs are available?

Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are fourteen patents protecting this drug.

This drug has three hundred and thirty-one patent family members in forty-one countries.

The generic ingredient in BREO ELLIPTA is fluticasone furoate; vilanterol trifenatate. There are twenty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fluticasone furoate; vilanterol trifenatate profile page.

Summary for Tradename: BREO ELLIPTA

Patents:14
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BREO ELLIPTA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-002Apr 30, 2015RXYesYes8,113,199► SubscribeY ► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-002Apr 30, 2015RXYesYes7,629,335► SubscribeY ► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-002Apr 30, 2015RXYesYes7,776,895► SubscribeY ► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-002Apr 30, 2015RXYesYes9,333,310► SubscribeY ► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-001May 10, 2013RXYesYes6,878,698► Subscribe ► Subscribe
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Expired Patents for Tradename: BREO ELLIPTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-001May 10, 20135,873,360► Subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-002Apr 30, 20155,873,360► Subscribe
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Non-Orange Book Patents for Tradename: BREO ELLIPTA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,361,787Phenethanolamine derivatives for treatment of respiratory diseases► Subscribe
7,541,350Formulation containing anti-inflammatory androstane derivative► Subscribe
6,750,210 Formulation containing novel anti-inflammatory androstane derivative► Subscribe
7,498,32117.beta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane derivative as anti-inflammatory agents► Subscribe
7,982,067Phenethanolamine derivatives for treatment of respiratory diseases► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: BREO ELLIPTA

Country Document Number Estimated Expiration
Norway2008006► Subscribe
European Patent Office2363121► Subscribe
European Patent Office1534367► Subscribe
Norway20030549► Subscribe
Portugal1775305► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: BREO ELLIPTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/026United Kingdom► SubscribePRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080111; UK EU/1/07/434/002 20080111; UK EU/1/07/434/003 20080111
C0028France► SubscribePRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI,EN PARTICULIER LE TRIFENATATE DE VILANTEROL.; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
439Luxembourg► SubscribePRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI
4 50004-2014Slovakia► SubscribePRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113
00664Netherlands► SubscribePRODUCT NAME: VILANTEROL, DAN WEL EEN ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER HET TRIFENYLACETAATZOUT; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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